510(k) K142122

RADAR VASCULAR COMPRESSION DEVICE by Advanced Vascular Dynamics — Product Code DXC

K142122 is an FDA 510(k) premarket notification submitted by Advanced Vascular Dynamics for the device "RADAR VASCULAR COMPRESSION DEVICE". The FDA issued a decision of Substantially Equivalent on December 4, 2014. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Advanced Vascular Dynamics has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2014
Date Received
August 4, 2014
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Vascular
Device Class
Class II
Regulation Number
870.4450
Review Panel
CV
Submission Type